Job Description

A Quality Assurance Specialist is required by Careerwise recruitment to work with our Clare based client.

Role of this position

Provide QA support and oversight to the Irish operations team ensuring compliance with EU, Irish and FDA cGxP regulatory requirements, company QMS and any other applicable regulations/standards. Generate and prepare quality documents e.g., SOP's and controlled documents e.g., SOPs and Training Material. Ensure compliant and adequate systems are in place to monitor investigations, CAPAs, audits and Quality Review Boards. Support the preparation, execution and follow up on regulatory inspections. Perform external audits of key suppliers and service providers where required. Provide QA review for the eQMS system documents.

JOB REQUIREMENTS

Experience working in a GxP environment including a minimum 5 years' experience in Compliance and Quality Assurance. 10 years of experience of working in a GMP regulated environment, biotechnology or related manufacturing is preferred. Experience in the operation and improvement of all aspects of a local QMS including investigations, change controls and CAPAs. Experienced in performing internal and/or external audits.